Aug 17- Bristol-Myers Squibb Co said on Friday the U.S. Food and Drug Administration approved its treatment, Opdivo, for patients whose lung cancer had progressed even after undergoing chemotherapy and at least one other therapy. Sales of both the drugs are neck and neck, with Opdivo generating $1.63 billion in the second quarter and Keytruda $1.67 billion.
Aug 16- A recent outbreak of illness at a Chipotle Mexican Grill restaurant in Ohio that affected hundreds of people was caused by a type of bacteria, local health officials said on Thursday. The outbreak that occurred last month was caused by clostridium perfringen, a type of food-borne disease that occurs when food is left at unsafe temperatures, health...
With gene editing and other frontiers looming, "this is not the right time to be making any moves based on the idea that we know what the risks are," said Stanford bioethicist Mildred Cho. Since then, much has been learned about safety, and last year the FDA approved the nation's first gene therapies, for cancer and an inherited form of blindness. It's time to let the FDA...
LONDON, Aug 15- A long-acting injection developed by GlaxoSmithKline and given once a month has proved as effective as standard daily pills for controlling the AIDS virus, lifting prospects for the British drugmaker's key HIV business. GSK's majority-owned ViiV Healthcare unit said on Wednesday the experimental two-drug injection of cabotegravir and...
Express Scripts is quietly building a side business: getting paid to help drug companies dispense a new generation of high-priced drugs.
LONDON, Aug 15- A long-acting injection developed by GlaxoSmithKline and given once a month has proved as effective as standard daily pills for controlling the AIDS virus, lifting prospects for the British drugmaker's key HIV business. GSK's majority-owned ViiV Healthcare unit said on Wednesday the experimental two-drug injection of cabotegravir and...
Aug 13- Amicus Therapeutics on Monday set an average price of $315,000 per year for its newly approved Fabry disease treatment, a price it believes is below that of the main existing treatment in the United States. Galafold- approved on Friday by U.S. regulators- is the first new Fabry disease treatment in the country in over 15 years, and will compete with Sanofi...
Aug 13- Amicus Therapeutics priced its new Fabry disease treatment at an average $315,000 per year in the United States, the company said on Monday. On Friday, the U.S. Food and Drug Administration approved Amicus's Galafold as the first oral therapy for the rare, sometimes fatal genetic condition in which accumulation of fat damages several organs.
Aug 10- Alnylam Pharmaceuticals Inc's drug for a rare hereditary disease won U.S. regulatory approval on Friday, becoming the first approved treatment from a new class of medicines that use gene silencing technology. Onpattro, also known as patisiran, will have an annual U.S. list price of $450,000 for the average patient, the company said. After taking into...
Meg Tirrell reports on the latest FDA drug approvals and their effect on the after hours trade.
The vote comes ahead of a final decision by the FDA on the drug's approval, which is expected by early October. The FDA typically follows the recommendations of its advisory panels, but is not obliged to do so. It is comforting to me that the drug is safe and effective within the parameters that we look at normally for infectious disease products, "said Peter Weina,...
Aug 8- A U.S. Food and Drug Administration expert panel on Wednesday voted in favor of approval of Paratek Pharmaceuticals Inc's antibiotic to treat bacterial pneumonia and skin infections. The vote comes ahead of a final decision by the FDA on the drug's approval, which is expected by early October. The FDA typically follows the recommendations of its advisory...
CHICAGO— Children's advocates want the American Psychological Association to condemn the tech industry's practice of using persuasive psychological techniques to keep kids glued to their screens. The group seeking intervention includes 60 U.S. psychologists, researchers, children's advocates and the Children's Screen Time Action Network, a project of...
Aug 7- Bausch Health Cos Inc, formerly known as Valeant Pharmaceuticals, topped Wall Street estimates for quarterly profit on Tuesday, driven by demand for its gastrointestinal disorder medicines. The company raised its 2018 forecast for adjusted earnings before interest, taxes, depreciation and amortization to between $3.20 billion and $3.35 billion, from...
SAN DIEGO _ Kura Oncology Inc. on Monday reported a loss of $14.7 million in its second quarter. The average estimate of four analysts surveyed by Zacks Investment Research was for a loss of 46 cents per share. Kura Oncology shares have increased 38 percent since the beginning of the year.
*FDA knocks back Remoxy as benefits do not outweigh risks. Aug 6- The U.S. Food and Drug Administration declined to approve Pain Therapeutics Inc's abuse-deterrent opioid treatment Remoxy for the fourth time, sending the company's shares down 35 percent to a record low. "They are kind of backed into a corner when their drug gets rejected and there does not seem to be...
Pain Therapeutics said on Monday that the U.S. Food and Drug Administration declined to approve its opioid drug for the management of severe pain as the benefits of the drug did not outweigh the risk.
Aug 6- Pain Therapeutics said on Monday that the U.S. Food and Drug Administration declined to approve its opioid drug for the management of severe pain as the benefits of the drug did not outweigh the risk. "This is a bizarre conclusion to reach, especially during a time of staggering human and economic toll created by opioid abuse and addiction," said Chief...
Aug 6- Pain Therapeutics' said on Monday that the U.S. Food and Drug Administration declined to approve the company's opioid drug for the management of severe pain as the benefits of the drug did not outweigh the risk. The drug developer also said it had initiated a strategic reorganization to align its resources to focus on Alzheimer's disease.
TAIPEI, Aug 6- Shares of Taiwan Semiconductor Manufacturing Company Ltd fell more than 1.2 percent on Monday after the world's largest contract chipmaker and Apple Inc supplier said a computer virus outbreak will hit its third-quarter results. A number of TSMC's computer systems and fab tools had been infected by a virus and it expected full recovery on...
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